sub:assertion {
  <http://purl.obolibrary.org/obo/DOID_526> bl:category bl:Disease .
  sub:association rdf:object <http://purl.obolibrary.org/obo/DOID_526> ;
    rdf:predicate bl:treats ;
    rdf:subject <https://identifiers.org/drugbank:DB00220> ;
    a rdf:Statement ;
    rdfs:label "viracept in combination with other antiretroviral agents is indicated for the treatment of hiv infection in the clinical studies described below efficacy was evaluated by the percent of patients with plasma hiv rna 4 copies ml studies 511 and 542 or 5 copies ml study actg 364 using the roche rt pcr amplicor hiv 1 monitor or 5 copies ml using the roche hiv 1 ultrasensitive assay study avanti 3 in the analysis presented in each figure patients who terminated the study early for any reason switched therapy due to inadequate efficacy or who had a missing hiv rna measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have hiv rna above 4 copies ml above 5 copies ml or above 5 copies ml at subsequent time points depending on the assay that was used study 511 was a double blind randomized placebo controlled trial comparing treatment with zidovudine zdv 2 mg tid and lamivudine 3tc 15 mg bid plus 2 doses of viracept 75 mg and 5 mg tid to zidovudine 2 mg tid and lamivudine 15 mg bid alone in 297 antiretroviral naive hiv 1 infected patients median age 35 years range 21 to 63 89 male and 78 caucasian mean baseline cd4 cell count was 288 cells mm 3 1 figure 1 figure 2 study 542 is an ongoing randomized open label trial comparing the hiv rna suppression achieved by viracept 125 mg bid versus viracept 75 mg tid in patients also receiving stavudine d4t 3 4 mg bid and lamivudine 3tc 15 mg bid patients had a median age of 36 years range 18 to 83 were 84 male and were 91 caucasian patients had received less than 6 months of therapy with nucleoside transcriptase inhibitors and were naive to protease inhibitors mean baseline cd4 cell count was 296 cells mm 3 1 results showed that there was no significant difference in mean cd4 cell count among treatment groups the mean increases from baseline for the bid and tid arms were 15 cells mm 3 3 the percent of patients with hiv rna 4 copies ml is summarized in figure 3 the outcomes of patients through 48 weeks of treatment are summarized in table 8 figure 3 study 542 percentage of patients with hiv rna below 4 copies ml table 8 outcomes of randomized treatment through 48 weeks outcome viracept 125 mg bid regimen viracept 75 mg tid regimen number of patients evaluable twelve patients in the bid arm and fourteen patients in the tid arm had not yet reached 48 weeks of therapy 323 192 hiv rna 4 198 61 111 58 hiv rna 4 46 14 22 11 discontinued due to viracept toxicity these rates only reflect dose limiting toxicities that were counted as the initial reason for treatment failure in the analysis see adverse reactions 9 3 2 1 discontinued due to other antiretroviral agents toxicity 3 1 3 2 others consent withdrawn lost to follow up intercurrent illness noncompliance or missing data all assumed as failures 67 21 54 28 study avanti 3 was a placebo controlled randomized double blind study designed to evaluate the safety and efficacy of viracept 75 mg tid in combination with zidovudine zdv 3 mg bid and lamivudine 3tc 15 mg bid n 53 versus placebo in combination with zdv and 3tc n 52 administered to antiretroviral naive patients with hiv infection and a cd4 cell count between 15 and 5 cells ul patients had a mean age of 35 range 22 59 were 89 male and 88 caucasian mean baseline cd4 cell count was 3 4 cells mm 3 1 study actg 364 was a randomized double blind study that evaluated the combination of viracept 75 mg tid and or efavirenz 6 mg qd with 2 nrtis either didanosine ddi d4t ddi 3tc or d4t 3tc in patients with prolonged prior nucleoside exposure who had completed 2 previous actg studies patients had a mean age of 41 years range 18 to 75 were 88 male and were 74 caucasian mean baseline cd4 cell count was 389 cells mm 3 1 the percent of patients with plasma hiv rna 5 copies ml at 48 weeks was 42 62 and 72 for the viracept n 66 efv n 65 and viracept efv n 64 treatment groups respectively the 4 drug combination of viracept efv 2 nrtis was more effective in suppressing plasma hiv rna in these patients than either 3 drug regimen" ;
    bl:association_type bl:ChemicalToDiseaseOrPhenotypicFeatureAssociation ;
    bl:provided_by <https://w3id.org/um/NeuroDKG> ;
    bl:relation schema:TreatmentIndication .
  <https://identifiers.org/drugbank:DB00220> bl:category bl:Drug .
}